In the current scenario of COVID-19, Diagnostic Kit (Extraction, Screening, Confirmation) is considered as one of the critical products for immediate supply. But with the decline in the global supply chains of extraction/screening/confirmation diagnostic kits, meeting the demand right on time would be challenging.
To ensure the world sustain the ever-growing demand in this time of emergency, as a prominent diagnostic kit manufacturer, you might be willing to market your product across the globe or to be specific in the USA. But do you know how different types of diagnostic kits are classified in the USA by the United States Food and Drug Administration (US FDA)? How US FDA regulates diagnostic kit?
Have all your questions answered regarding:
- Diagnostic Kit Registration/notification in the USA
- US FDA Diagnostic Kit Regulations
In addition, some global health authorities have already expedited their Regulatory pathways for diagnostic kit (extraction, screening, confirmation). The dynamic nature of those developments might require manufacturers to be more attentive on the regional Regulatory aspects, too. In such a case, streamline diagnostic kits global market entry with the best of regional Regulatory information and structural Regulatory approach.
As a responsible Regulatory partner, Freyr has already started assisting clients to accelerate and fast track registrations/notifications of diagnostic kits in the USA.